CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 48 enrolled
Drug / intervention
Methylnaltrexone only +3 moredrug
Likely dose
Methylnaltrexone only 0.30 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01055704
NCT01055704Phase 4Completed
CompareCT.gov

Effect of Methylnaltrexone on Gastrointestinal and Colonic Transit in Health

Mayo Clinic·interventional·Posted Jan 26, 2010·Updated Jun 25, 2012

In Brief

A Phase 4 clinical trial evaluating Methylnaltrexone only, Codeine only, and 2 other interventions for Gastric Motility Disorder. Completed, enrolled 48 participants across 1 site.

Detailed Summary

This is a single-center, randomized, double blind, placebo-controlled study evaluating the effects of placebo, codeine, methylnaltrexone and codeine with methylnaltrexone on gastrointestinal motility and colonic transit of solids in healthy human subjects. The hypotheses are: 1. Methylnaltrexone administered subcutaneously enhances gastrointestinal motility with acceleration of overall colonic transit, and ascending colon emptying of solids in healthy humans. 2. Methylnaltrexone significantly accelerates colonic transit that is delayed by codeine

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastric Motility Disorder
CountriesUnited States
CollaboratorsWyeth is now a wholly owned subsidiary of Pfizer

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 26, 2010
Enrollment StartNov 1, 2009
Primary CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 16.4 years ago

Interventions

Methylnaltrexone onlydrug

0.30 mg/kg subcutaneous injection daily

Codeine onlydrug

30 mg taken orally four times daily for 5 days

Methylnaltrexone + codeinedrug

Methylnaltrexone 0.30 mg/kg by subcutaneous injection once daily and codeine 30 mg taken orally four times daily for 5 days

Placebo + placebodrug

Placebo subcutaneous injection once daily and placebo taken orally four times daily for 5 days